510(k) · Cleared
ClearedSangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sangui Biotech, Inc. · GGT Assay, Erythropoietin
Cleared on Jun 7, 2000 after a 293-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 7, 2000
- Review
- 293 days
- Class
- Class II
- Product code
- GGT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK992799 Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSangui Biotech, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK052223 Access Epo AssayBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK240182 Access EPOBeckman Coulter, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK183088 ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit | Sangui Biotech, Inc. | 2000 | — |
| +1 | K052223 | Access Epo Assay | Beckman Coulter, Inc. | 2006 | 1 |
| +2 | K240182 | Access EPO | Beckman Coulter, Inc. | 2024 | — |
| +2 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GGT device
- #1 K240182 Access EPOscore 7.8 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Nichols Institute Diagnostics EPO [Erythropoietin] Assay Chemiluminescent Assay (Coated… Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052223 | Access Epo Assay | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052223 (Beckman Coulter, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GGT devicesGGT Assay, Erythropoietin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GGT
Too few GGT 510(k)s in any year since 2007 to give a median.
Recalls per year · GGT
No recall names GGT since 2007.
Adverse event reports per year · GGT
3in 2012
MAUDE reports naming product code GGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992799
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026